FDA Guidance - general wellness products - wearables

[MikeKilkelly]

Has anyone got experience with categorising products as a general wellness product rather than medical device.
I have a few questions:

1. Does the manufacturer self-declare that their product is part of the general wellness category?
2. Can manufacturers use the general wellness exemption for a product that could be interpreted to be similar to devices that have a classification regulation? For example, an oximeter, thermometer, breath counters, etc.
3. The guidance says that inclusion under the policy does not establish that is has been shown to be safe and/or effective for its intended use, are there any FDA recommendations for manufacturers to consider when determining how they want to show safety and effectiveness of a general wellness product?

 

[yodon]

First, I would suggest you consult with a professional Regulatory Affairs person (I'm not).

As far as I know, there's no formal self-declaration required. It's essentially just a consumer product. There are other agencies that may have a play; e.g., FCC if you have wireless communication, FTC for general consumer protection, etc.

Once you get into oximeter and thermometer measurements, though, you may be crossing the line. (Again, an RA pro can help.)

As far as safety and effectiveness, I believe that's your call if it's outside the scope of a medical device. Off the top of my head, I can think of a number of things:

• population for the intended use (and that it consistently works across the population; e.g., youth, adults, sex, ethnicity, etc.)
• the spectrum of environmental conditions (heat, cold, humidity as well as other factors like sweat, impact, etc.)
• accuracy of any measurements (across the population and environmental conditions)
• whether it is interfering with anything (like a pacemaker) and whether anything (like a cell phone) is interfering with it.

 

[Gish]

Hi Mike,
Just getting recently reacquainted with Elsmar Cove since its revival. Judging by the date of your post, you may have gotten these questions answered elsewhere
The short answers are:
1 - Yes.
2 - No.
3 - Doesn't apply. (Great job by Yodon with fleshing this out with what you might want to gather as part of your internal product risk management dossier.)

 

[duinyk]

So, I have a similar situation where a product my client is trying to bring to the market can qualify as a General wellness low risk product. My strategy was to build up some kind of wellness exemption justification package which will basically say why and how we see the device to be a wellness device and not a medical device. Something like a letter to file. So, my question is has anyone done something like this before and are there any like templated structured file one could use?

Thanks

 

[Icculus]

So, I have a similar situation where a product my client is trying to bring to the market can qualify as a General wellness low risk product. My strategy was to build up some kind of wellness exemption justification package which will basically say why and how we see the device to be a wellness device and not a medical device. Something like a letter to file. So, my question is has anyone done something like this before and are there any like templated structured file one could use?

Thanks

I've used a LTF for this exact purpose: to document the justification that a particular application qualifies as a general wellness product rather than a medical device. In general, I use LTF's for the purpose of documenting all kinds of memos, and not only for 510(k) decisions.

 

[Ajit Basrur]

Agree, documenting on a a LTF would be ideal